Login| Sign Up| Help| Contact|

Patent Searching and Data


Title:
FOAM INHALATION DEVICE
Document Type and Number:
WIPO Patent Application WO/2023/110062
Kind Code:
A1
Abstract:
A process for the preparation of a consumable to be ingested through the human mouth in small doses comprising at least partial mixing of at least one liquid and at least one substance, whereby the liquid and/or the substance serve as an active ingredient carrier

Inventors:
HAGEN KLAUS (DE)
Application Number:
PCT/EP2021/085671
Publication Date:
June 22, 2023
Filing Date:
December 14, 2021
Export Citation:
Click for automatic bibliography generation   Help
Assignee:
SPLASH TM GMBH (DE)
International Classes:
A61K9/00; A61M15/00; A61M15/06
Domestic Patent References:
WO2021204408A12021-10-14
Foreign References:
GB2593789A2021-10-06
GB2586301A2021-02-17
Attorney, Agent or Firm:
PATENTANWÄLTE SCHULTE & SCHULTE (DE)
Download PDF:
Claims:
9

PATENT CLAIMS

1. Process for preparing a consumable serving for absorption through the human mouth in low-dose amounts by at least partial mixing of at least one liquid and at least one substance, whereby the liquid and/or the substance serve as an active ingredient carrier.

2. Process in accordance with claim 1 , characterised in that the mixing of at least one liquid and at least one substance is carried out in a device for the preparation and delivery of low-dose amounts of the consumable, preferably in an inhalation device.

3. Process in accordance with claim 1 , characterised in that the liquid comprises a foam emulsifier and/or a foam stabilizer.

4. Process in accordance with claim 1 , characterised in that the proportion of foam emulsifier and/or foam stabilizer in the liquid is 10% to 30%, preferably about 20%.

5. Process in accordance with claim 1 , characterised in that a lecithin, mono- or diglyceride, xanhan, maltrodextin, aspuma, agar and/or SucroAir serve as a foam emulsifier and/or as a foam stabilizer.

6. Process in accordance with claim 1 , characterised in that foam formation is accompanied by activation of the active substance.

7. Consumable used for ingestion through the human mouth in low-dose quantities, prepared by at least partial mixing of at least one liquid and/or at least one substance in a device, preferably in an inhalation device.

8. Inhalation device (14) for the production and delivery of low-dose amounts of a consumable by at least partial mixing of at least one liquid and at least one substance, characterised in that the inhalation device (14) has at least one holder (12) for at least one capsule (1) used for the storage of liquid or substance.

9. Capsule (1) for insertion into an inhalation device (14) for the preparation and delivery of low-dose amounts of a consumable by at least partial mixing of a liquid and a substance, held in at least two chambers (3, 4) of the capsule (1), whereby the liquid and/or the substance serve as an active ingredient carrier.

10. Capsule in accordance with claim 9, characterised in that the liquid comprises a foam emulsifier and/or a foam stabilizer.

11. Capsule in accordance with claim 10, characterised in that the proportion of foam emulsifier and/or foam stabilizer in the liquid is 10% to 30%, preferably about 20%.

12. Capsule in accordance with claim 9, characterised in that lecithin, mono- or diglyceride, xanhan, maltrodextin, aspuma, agar and/or SucroAir serve as a foam emulsifier and/or as a foam stabilizer. 11

13. Capsule in accordance with claim 9, characterised in that foam formation is accompanied by activation of the active substance.

14. Capsule in accordance with claim 9. characterised in that nicotine, caffeine, alcohol, a vitamin mixture, light pharmaceutical substances and/or sleeping pills serve as active ingredient.

15. Capsule in accordance with claim 9, characterised in that the liquid with foam emulsifiers and/or foam stabilizers serves as a flavour enhancer.

16. Capsule in accordance with claim 9, characterised in that an effervescent serves as the active ingredient carrier.

17. Capsule in accordance with claim 9, characterised in that the capsule (1) is equipped with an activation mechanism (13), the actuation of which is accompanied by at least partial mixing of the substance and the liquid medium.

18. Capsule in accordance with claim 17, characterised in that the two chambers (3, 4) are shielded from each other before actuation of the activation mechanism (13). 12

19. Capsule in accordance with claim 17, characterised in that the activation mechanism (13) includes a needle or tube used to break through the wall between the chambers.

20. Capsule in accordance with claim 17, characterised in that the activation mechanism (13) includes a needle or tube used to discharge the foam produced from the capsule (1).

21. Capsule in accordance with claim 19 or 20, characterised in that a needle or tube is used to break through the wall between the chambers (3, 4) and to discharge the foam produced from the capsule (1).

22. Capsule in accordance with claim 4, characterised in that the inhaler (14) is fitted with a stirring or grinding device.

Description:
DESC RI PTI ON

FOAM INHALATION DEVICE

The invention relates to a process for preparing a consumable serving for absorption through the human mouth in low-dose amounts by at least partial mixing of at least one liquid and at least one substance, whereby the liquid and/or the substance serve as an active ingredient carrier.

In addition, the invention relates to a consumable for absorption through the human mouth in small doses, prepared by at least partial mixing of at least one liquid and/or at least one substance in a device, preferably in an inhalation device.

In addition, the invention relates to an inhalation device for the preparation and delivery of low-dose amounts of a consumable by at least partial mixing of at least one liquid and at least one substance.

Finally, the invention relates to a capsule for insertion into an inhalation device for the preparation and delivery of low-dose amounts of a consumable by at least partial mixing of a liquid and a substance, held in at least two chambers of the capsule, wherein the liquid and/or the substance serve as an active ingredient carrier.

Inhalation devices or inhalers are mainly familiar from medicine. They are used to generate aerosols, which are then inhaled by patients as part of therapy. It is important that the active ingredients are specifically and precisely absorbed by the lungs, e.g. to remedy pulmonary or colds.

Mixtures of effervescent powder and water have always enjoyed great popularity, especially among children and young people. Sufficiently known are e.g. sherbets as carbonated soft drinks. For this purpose, powder usually available in bags is mixed in a glass, cup or even in the bag to a bubbling effervescent drink. Because the powder is supposed to react intensively with the water, it comes beyond the pure drinking pleasure to a fun factor associated with the production of the drink. Such devices are known from the GB 2586301 . The teaching of GB 2586301 discloses the chemical reaction of a substance that releases carbon dioxide gas to form the foam of the soft drink according to the invention and e.g. provides for the endothermic reaction between soda and citric acid. In pure water, CO 2 forms unstable, short-lived bubbles at the I iquid/gas interface. Bubbles burst immediately due to the high surface tension.

Starting from this state of the art, the present invention has the task of creating a process for the preparation of a suitable consumable, a consumable, an inhalation device for the preparation and delivery of low-dose amounts of such a consumable and a capsule for insertion into an inhalation device for the preparation and delivery of low-dose amounts of a consumable.

This purpose is achieved by a manufacturing process in accordance with claim 1 .

In particular a capsule for insertion into an inhalation device for the preparation and delivery of low-dose amounts of a foam-like soft drink is given. A liquid and a substance are each stored in a chamber of the capsule and then specifically destroyed via the activation to such an extent that a deliberate and intentional leak of the mixture occurs.

Furthermore the above mentioned purpose is achieved by a consumable in accordance with claim 7.

Such a consumable may be enjoyed in a low-dose quantity such as a shot. This foam production then exits the capsule and enters the consumer's body through the inhaler. Moreover this purpose may be achieved by an inhalation device in accordance with claim 8.

The object of this application enables consumers to enjoy refreshing and energizing water or substance in portions as conveniently, clean and safely as possible. Thus, a process for the preparation and also for the delivery of low-dose amounts of a consumable according to the invention is given. A liquid and/or a substance serve as an active ingredient carrier. They are each stored in a chamber in a capsule and then specifically destroyed via the activation mechanism at least to such an extent that it comes to a deliberate and intentional leakage of the mixture.

Finally this purpose may be achieved by a capsule in accordance with claim 9.

It depends on the composition of the active ingredient: the active ingredient can be a "ready mixed" formula like an energy drink or an alcoholic composition (like any cocktail, wine or any pre-bottled alcohol) or it can be an “add on” raw material of those substances that are called “active ingredients” (like some caffeine powders or some drops of nicotine). In the case of a “ready mixed” active ingredient formula the percentage can vary from 50-100%, and in the case of an "add on" raw material it can vary from 1-10%.

An important role is played by the liquid and the substance, which can occur together or alone as an active ingredient carrier. Particularly advantageous in this context is the device for the production and delivery of low-dose amounts of the consumable.

In the sense of a device, an inhalation device for the production and delivery of low-dose amounts of a consumable by at least partial mixing of a liquid and at least one substance is possible. This applies in particular to the capsule used for the storage of liquid or substance, which is installed in the inhalation device or connected to it in a suitable way.

It is provided specifically for the inhalation device that this comprises at least two chambers, which serve to receive a liquid or a substance. However, mixing only occurs under the condition that the consumer activates a manufacturing process by destroying e.g. the partition wall between different chambers. This foam production "on site" then exits the capsule and enters the consumer's body through the inhaler.

The initial step of this process is the tablet solvation in contact with water forms hydrated ions with the duration like slow, taking several minutes. The main reaction is about an instable hydrogen carbonate ion break down into water and gaseous CO 2 , very fast, <1 ms. Whilst the third step is the CO 2 release showing CO 2 bubbles are formed when saturation limit is reached. The duration for this third step is rather fast.

As for the capsule for insertion into an inhalation device, the capsule is part of a multi-chamber system whose function is triggered and/or controlled by a suitable activation mechanism. Foam as such proves to be an excellent carrier for active ingredients of any kind, because these substances are activated during foam formation and are immediately available for use in connection with an inhalation device according to the invention. As soon as the foam enters the mouth, it is quickly absorbed directly into the bloodstream via the oral mucosa so that it can unfold its desired effect.

A preferred embodiment of the invention provides that the liquid comprises a foam emulsifier and/or a foam stabilizer. One effect is that the surface tension is reduced by dispersing small amounts of emulsifiers or surfactants.

Depending on the exact amount of the individual substances, various foodsafe substances can be used as a foam emulsifier or foam stabilizer, which must be added to the formulation according to the invention to obtain a fine and stable foam.

It has been found that the proportion of foam emulsifier and/or foam stabilizer in the liquid should be 10% to 30%, preferably about 20%. The foam formation rate is mainly determined by the solvation speed of acid and carbonate mixtures. A powder dissolves much faster in comparison to a compressed tablet. Fine adjustment is achievable by pressing the tablet at different forces that result in increasing hardness at higher forces. Tablet solvation can range from a couple of seconds up to several minutes. Physical properties, mainly viscosity and density of liquid can impact foam formation speed as well. The lower liquid’s fluidity becomes the longer foam generation takes. The development target is about longlife stable and white foam with homogenous bubbles are as distribution. The lifetime of bubbles is limited by a mechanical cracking, water evaporation, gravimetry and the gas type.

Furthermore, it has been proven that lecithin, mono- or diglyceride, xanhan, maltrodextine, aspuma, agar and/or SucroAir expediently serve as a foam emulsifier and/or as a foam stabilizer. The use of further emulsifiers and stabilizers is conceivable. Consumers take foam in portions of 0.1 to 0.3 gram from the device. This amount can be adjusted by the density of the mouth and filter plug and depends on users inhaling behaviour. That means how long someone presses the valve button and how intensely the user inhales. The relatively small amount provides the surprisingly intense taste and smell sensation.

The starting point for a foam in the sense of the invention is two or more substances that are held separately in such a capsule until the wall between the two or more chambers is broken, which can trigger the process of merging these substances and their distribution for consumption. In this context, it is worth mentioning that foam formation is accompanied by an activation of the active ingredient. The process according to the invention teaches that the foam is only produced when the consumer activates the foaming process, for which the partition wall between the individual chambers has to be broken through. Referring to the tab, the liquid filling volumes range from 3.5 to 4mL, all kinds of water-based juices and beverages with dispersed emulsifiers are suitable. Referring to the tab the standard recipe is 40/60 mixture of citric acid and sodium hydrogen carbonate.

The maximal foam volume can be estimated from the reaction equation of the effervescent tablet. One tab delivers 68 mL. Assuming a los of 5% for dissolved CO 2 in the liquid, an over pressure inside the bubbles of about 5% and a loss of 10% at the interface between foam and ambient air a total foam volume of about 55 mL could be achievable.

There are almost no limits as far as the selection of active ingredients is concerned. It is to be regarded as advantageous if nicotine, caffeine, alcohol, a vitamin mixture, light pharmaceutical substances and/or sleeping pills serve as active ingredients, i.e. stimulating or calming substances as well. The active ingredient can be a "ready-made" formula, as is the case for an energy drink or an alcoholic composition, as is ultimately the case with any alcoholic beverage. The proportion of active ingredient is between 50% and 100%, with an additive this can preferably vary between 1 % and 10%.

It is conceivable that an effervescent serves as an active ingredient carrier, while the liquid with foam emulsifiers and/or foam stabilizers serves as a flavour enhancer, that the emulsifiers and stabilizers thus take over the role of such a flavour enhancer.

It has already been mentioned several times that a special activation mechanism is used to activate the capsule in question. In this sense must the proposal be understood that the capsule is equipped with an activation mechanism, the actuation of which is accompanied by at least partial mixing of the substance and the liquid medium. Therefore, only when the activation mechanism is activated does the destruction of the walls between the previously sealed chambers and the associated mixing of substance and liquid medium occur. As has already mentioned several times, this basically only works if the two chambers are shielded from each other before actuation of the activation mechanism and the two substances that are stored there do not naturally come into contact with each other and thus potentially react with each other.

The fact that the activation mechanism comprises a needle or tube used to break through the wall between the chambers reflects the first function of such a mechanism, namely the destruction of a chamber wall by means of the activation mechanism as a function of the pressure applied manually to the capsule.

A further advantageous embodiment of the invention provides that the activation mechanism comprises a needle or a tube which serves as an agent for the exit of the generated foam from the capsule.

According to another variant, it is intended that a needle or tube serves to break through the wall between the chambers and to expel the generated foam from the capsule. The mechanical instrument in the form of a needle or tube thus ideally works in a double function.

This foam production "on site" then exits the capsule and enters the consumer's body through an inhaler in which the capsule is inserted or by being an integral part of an inhaler. This is to be understood as a needle or tube used to break through the wall between the chambers and to expel the generated foam from the capsule.

To achieve the maximum effectiveness of the formula, it can be prepared in various ways by mixing or supporting measures before storage in one of the chambers of the capsule. Simple stirring is intended or above all professional, even grinding of the substances, if necessary paired with a stirring of the substances with rotors that work with very high torques. For this purpose, the inhaler is designed with a stirring or grinding device. The invention is characterized in particular in that a capsule for insertion into an inhalation device for the preparation and delivery of low-dose amounts of a foam-like soft drink is given. A liquid and a substance are each stored in a chamber of the capsule and then specifically destroyed via the activation mechanism at least to such an extent that a deliberate and intentional leak of the mixture occurs. A special role is played by the liquid and the substance, which together or alone can serve as an active ingredient carrier, supported by a foam emulsifier and/or a foam stabilizer. In this context, it is important that the foam formation leads to the activation of the active ingredient. That is, the foam is only produced when the consumer activates the foaming process by destroying the partition between the different chambers. This foam production "on site" then exits the capsule and enters the consumer's body through the inhaler. In case of this invention soda/citric acid mixes are preferred because of their neutral taste and excellent foam formation potential. Particle size and shape of acid and carbonate must fit for a proper compressibility in the tablet pressing process on a homogenous distribution.

Further details and advantages of the subject matter of the invention result from the following description of the associated drawing, in which a preferred embodiment with the necessary details and individual parts is presented.

The figure shows a capsule 1 set in a inhalation device 14 which has a flexible mixing chamber 2, an expansion chamber 10 and a seal/connection 5 as well as an outlet 8. There is a holder 12 for the capsule 1 . The mixing chamber 12 is designed to be flexible and is used to hold a liquid in the case of the chamber 3 and to hold a substance in the case of the chamber 4. An activation mechanism is denoted by 13, which is used to destroy the chamber 3 for the purpose of mixing or expansion. The conduit 6extends between an inlet 7and an outlet/mouthpiece 8 There are two parts 9 and 11 of the housing.